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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals IV Medications Recalled for Manufacturing Violations

Agency Publication Date: May 2, 2022
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Summary

SCA Pharmaceuticals is recalling specific lots of Norepinephrine (8mg in 0.9% Sodium Chloride), Fentanyl (2mcg/ml) and Bupivacaine (0.125%), and Vancomycin HCl (1.5 g) IV bags. Verbatim, the quantity affected includes 120 bags of Norepinephrine, 424 bags of Fentanyl/Bupivacaine, and 30 bags of Vancomycin. The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards, which may affect the quality and safety of the medications. These products were distributed nationwide to hospitals and healthcare facilities. No incidents or injuries have been reported to date.

Risk

Manufacturing practice violations can compromise the sterility or stability of medications intended for intravenous use. In a clinical setting, using drugs that do not meet strict quality standards could lead to suboptimal treatment outcomes or health complications for patients.

What You Should Do

  1. This recall affects Norepinephrine 8mg, Fentanyl/Bupivacaine, and Vancomycin HCl 1.5g IV bags manufactured by SCA Pharmaceuticals in Windsor, CT.
  2. Check inventory for Norepinephrine (NDC 70004-078-40) lot 1222035815 with expiration date 10-Jul-22.
  3. Identify Fentanyl/Bupivacaine (NDC 70004-0231-32) by checking for lot 1222035837 (Exp. 22-Jul-22) or lot 1222035804 (Exp. 25-Jul-22).
  4. Identify Vancomycin HCl (NDC 70004-0924-44) by checking for lot 1222035839 with expiration date 09-Aug-22.
  5. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Norepinephrine 8mg in 0.9% Sodium Chloride (250 mL bag)
Variants: 8mg, 250 mL bag
Lot Numbers:
1222035815 (Exp. 10-Jul-22)
NDC:
70004-078-40

Rx only

Product: Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride (100 mL bags)
Variants: 2mcg/ml, 0.125%, 100 mL bags
Lot Numbers:
1222035837 (Exp. 22-Jul-22)
1222035804 (Exp. 25-Jul-22)
NDC:
70004-0231-32

Rx only

Product: Vancomycin HCl 1.5 g in 0.9% Sodium Chloride (500 mL bags)
Variants: 1.5 g, 500 mL bags
Lot Numbers:
1222035839 (Exp. 09-Aug-22)
NDC:
70004-0924-44

Rx only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90080
Status: Resolved
Manufacturer: SCA Pharmaceuticals
Sold By: Hospitals; Healthcare Facilities
Manufactured In: United States
Units Affected: 3 products (120 bags; 424 bags; 30 bags)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.